Certificates

13485:2016

ISO 13485:2016 is a standard for the design and manufacture of medical equipment. It is an independent standard certification that is generally harmonised with ISO 9001:2015. The standard has been prepared in accordance with the European Commission with a view to the essential requirements of EU directives for medical devices and CE marking. For ARCTIKO, the ISO 14385:2016 is a quality management system ensuring that our products meet the EU directive 93/42/EEC for medical devices.

9001:2015

ISO 9001:2015 is the most widely used International standard in the world. It streamlines and documents ARCTIKO’s working processes and ensures that production always meets the high-quality expectations of ARCTIKO’s partners.

Medical Device Directive

EU directive 93/42/EEC for medical devices & CE marking for Class II equipment.

FDA

ARCTIKO is registered and has listed the following medical device with the U.S. Food and Drug Administration for FY 2016 Pursuant to Title 21, 807 et seq. of the United States Code of Federal Regulations.

ETL

ARCTIKO products are approved according to the following standard(s): UL 471 issued: 2010/11/24 Ed.: 10 Rev: 2014/11/17 Commercial Refrigerators and Freezers. CSA C22.2#120 Issued: 2013/03/01 Ed: 4 Refrigeration Equipment.